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"This text contains Dr. Henney's prepared remarks. It should be used with the understanding that some of the material may have been added or deleted during actual delivery."

Remarks by:Jane E. Henney, M.D.

CONFERENCE OF THE NATIONAL TASK FORCE ON CME PROVIDER/INDUSTRY COLLABORATION

"FDA PERSPECTIVE ON PRODUCT PROMOTION ISSUES"

WASHINGTON, D.C.

SEPTEMBER 24, 1999

Good morning, it is a pleasure to be here today. Since my return to the agency over 10 months ago, there are many things that I have learned about being Commissioner. For one thing, I have found my responsibilities to be challenging, demanding, and fulfilling.

But, being a forthright and candid person, by nature, I have found that one of the greatest challenges of being a Commissioner is to have to respond to questions by saying "We are currently in litigation over that issue, therefore I cannot comment."

While I am unable to discuss the headlined material today, there are always other topics of importance at the Agency and I have selected a few of those to discuss today.

As you know, the Food and Drug Administration has a very broad mission that includes assuring that the food supply is safe and that medical products on the market are safe and effective for their intended uses. Risk management is a critical part of our overall mission and day-to-day work. Along with the many other tasks that the Agency is expected to accomplish, probably none is more important or better known by the public than the Agency's review of new products for marketing-including drugs, biologics, and medical devices. The most critical aspect of this review is the evaluation of the risks and benefits associated with each new product.

These safety determinations that FDA must do each day are a critical part of protecting the public health. For each product, the FDA always considers the risks relative to the benefits associated with that product. Every single drug-indeed, every single medical product--has risks. Some side effects are rare, and some are not very serious. But for every drug that we approve, we balance the benefits of the drug against its risks. FDA cannot make these risks go away--and we should not, as an Agency--represent that we can. We need to be clear about not only what the benefits of a particular product are, but also what the risks are, and then communicate that information as effectively as possible to all involved.

The majority of injuries and deaths in this country from medical products are from known side effects, not from the unexpected ones. Therefore, although it is important to evaluate FDA's standards in its premarket decision-making, it's also important to look at whether risks are managed effectively throughout the health care delivery system and whether adequate safeguards are in place to properly promote as well as protect the public health.

Let me emphasize that all participants in the medical product development and delivery system have a role to play in maintaining this benefit/risk balance by making sure that products are developed, tested, manufactured, labeled, prescribed, dispensed, and used in a way that maximizes benefit and minimizes risk. After the Agency has approved a product for marketing, determinations about the safety of a product become the shared responsibility of health care professionals and the patients themselves, particularly when is comes to prescription drugs. Drugs are available by prescription for a reason-and it has to do with the continued need to monitor and manage the risk/benefit ratio, from the direct involvement of the physician who prescribed the drug-to the pharmacist who dispensed it to the patient.

When a product is available for over-the-counter use, the FDA has made a determination that an individual patient or consumer is capable of weighing the benefits and risks from use of the product on their own.

In all cases involving drugs-from those that are undergoing investigation in the clinical trial setting-those available by prescription-to those obtained over the counter at the supermarket or drug store--patients are the ones who are assuming the risk, and we know that individuals weigh risk differently. Some patients-usually the desperately ill-want to assume more risk for even a minimal chance of benefit. The "almost well" with a head cold or headache want risks kept at a minimal level. In each case along this spectrum, patients can actively engage in minimizing their risk by reading labels, keeping track of their medications, keeping track of the basic side effects, and simply-but importantly--asking questions.

To assure that the risk management system is working at an optimal level, it is critically important that healthcare providers, patients, and consumers have accurate, reliable information in order to make informed decisions about the risks and benefits of certain therapies. Product information made available to the patients and the health care community comes from a variety of sources-at least three of which are important to this group, including direct-to-consumer advertising, the Internet, and Continuing Medical Education seminars. These mechanisms for dissemination of information to health professionals, patients, and consumers provide great promise, but have also created some complex regulatory challenges for the Agency.

First, direct to consumer broadcast advertising. Providing truthful, balanced, and non-misleading information to patients and consumers can be a very good thing. People believe that more information allows them to make more informed choices about their health care, and allows them to play a more active role as their own risk managers. Accurate direct to consumer advertising allows patients to be more informed when they speak to their doctors or pharmacists, and to communicate more effectively with them.

In one recent survey, confirming earlier results, about a third of patients who saw an advertisement for a medicine they are taking said that seeing the ad made them more likely to take their medicine regularly, and a third of them reported that seeing an ad reminded them to get their prescription refilled. Studies also indicate that direct-to-consumer advertising brings more people in to see their doctors, prompting them to deal with health issues that they may have otherwise ignored. In one recent survey, 14 percent of consumers reported that after seeing DTC advertising, they talked about a medical condition or illness that they had never previously mentioned to their doctor.

Further, if consumers know more about the risks of their medications, they may be more likely to be alert to side effects as well as symptoms of adverse reactions, and to report them earlier, when side effects, or something more unexpected, can be dealt with more effectively.

However, some critics of direct to consumer broadcast advertising suggest that what is really happening is that patients are now seeing a DTC ad and demanding medications from their doctors that they do not actually need. Yet, while the amount of DTC ads has dramatically increased in recent years, the number of prescriptions written in response to specific requests does not appear to have increased. Instead, it could be argued that due to DTC advertising, patients are now talking to their doctors after receiving more accurate and balanced data, as opposed to information traditionally received through word of mouth from friends, relatives, or neighbors.

The most important message that we at FDA have tried to stress regarding DTC advertising is that a manufacturer must give the whole picture. When discussing the benefits of a given product, the risks must be effectively communicated at the same time. As you are well aware, these requirements come directly from our statute and regulations-this information must be truthful and non-misleading, and part of being "non-misleading" is providing an adequate amount of risk information when discussing the benefits of a product.

In August of this year, the Agency issued its final regulatory guidance on broadcast direct-to-consumer advertising. The guidance presumes several things about all direct-to-consumer advertisements, including: that they are not false or misleading; that prescription drug products are to be advertised as being available only through a prescription--only a healthcare professional can decide whether they are appropriate for a patient; that the ad must maintain a fair balance between effectiveness information and risk information; and that the information about the product's most important risks (major side effects and contraindications) must be communicated in consumer-friendly language.

The main point of the guidance is to provide information regarding ways to comply with the "adequate provision" requirement for broadcast advertisements. The guidance mandates that manufacturers must make package labeling information for the advertised drug readily available to the public in connection with the ad. All of the following methods for disseminating this information must be provided: a toll-free telephone number, a reference to another advertisement in print, a reference to an Internet page, and disclosure that healthcare providers may provide consumers with additional information about the product.

This guidance has been issued to communicate relevant information to manufacturers and aiding them in complying with our regulations. We have made a great effort to work with sponsors to ensure that their advertising is in compliance with the applicable laws.

There are instances that remain where the direct marketing of certain types of drugs to consumers has raised important public health issues, including ads for controlled substances, antibiotics, and psychotropic drugs all raise certain public health issues. We are continuing to work with sponsors to sort through an appropriate way to communicate without changing risks and benefits of the product in question.

A critical analysis of direct-to-consumer advertising will be needed to understand and see its effects on patients, consumers, prescribers, and the health care system as a whole. At the time of the 1983 moratorium on DTC, there was very little study data in this area. Sixteen years later, many gaps still exist in our knowledge about the effects of DTC. We are now getting better consumer information: an AARP study, a National Consumer's League study, and surveys conducted by Time, Inc. and Prevention magazine. While surveys are one source of information, we also need more scientific information in order to fully understand this area.

Some health professional groups and managed care organizations would also like to see additional data regarding the costs and benefits of DTC to doctors, and to the health care system as a whole. These are some examples of the gaps that currently exist, and where additional study would be beneficial.

Let me turn to yet another area of extraordinary promise, but also regulatory challenge--the Internet. The sale of consumer products over the Internet has grown rapidly, including the sale of drugs and other medical products. Growth in online prescription drug sales by reputable pharmacies is a trend that could be beneficial to consumers. Access and convenience-particularly for those who are disabled or those who live in rural or frontier areas--privacy, and sometimes cost savings can be beneficial attributes of online drug sales.

We at FDA also use the power of the Internet to provide information to the public about FDA-regulated products, and we rely on this medium as a way for manufacturers to provide data regarding their products. The Internet can be a tool in providing information to patients and consumers in order to make risk/benefit decisions about their health care.

But, the Internet also provides increased risks to unsuspecting purchasers and some unique challenges to us at FDA. We are concerned about the public health implications of Internet drug sales, where the patient or consumer is able to bypass all the traditional public health safeguards in our risk management system set in place not only by the premarket approval activities of FDA, but by the health professionals who write prescriptions or dispense drugs. Risks include side effects from using inappropriately prescribed medications, dangerous drug interactions, contaminated drugs, and the possible ill effects of impure or unknown ingredients that may have gotten into unapproved drugs during the manufacturing process.

Of particular concern are the web sites that offer prescription drugs based only on a questionnaire. Unlike the traditional relationship between a patient and the patient's healthcare practitioner, many online practitioners issue prescriptions in the absence of a physical examination or direct medical supervision. As a consequence, patients are more likely to inappropriately receive a medication, thereby placing themselves at greater risk for side effects and drug interactions. By avoiding the inconvenience of an office visit, a patient may also have foregone the one opportunity for a healthcare practitioner to correctly diagnose the true cause of his or her condition or identify a contraindication to the use of the sought after medication.

FDA's role in making premarket review and prescription designation decisions was established to safeguard the public health. Congress requires that FDA classify certain medications as prescription drugs for a reason -- these drugs cannot be safely used by patients without a practitioner's supervision. Although patients can provide false or incorrect information both online and during an office visit, a face-to-face encounter allows the practitioner to take into account each patient's individual needs and then conduct a physical examination.

Some specific examples of real cases that highlight some of the dangers that we have seen in this area include: a 16-year old boy, who, through discussions in a chat room, was targeted by an adult male who supplied the boy with prescription drugs normally prescribed for pre-sex change patients; and a case involving a woman who was able to purchase phentermine, a controlled prescription drug, over the Internet without a prescription for purposes of a suicide attempt. These are just a couple of examples that illustrate the dangers that can occur with this medium...they may seem extreme, but we are doing what we can to see that they are not frequent.

We are currently responding to concerns about Internet sales as part of our overall goal of developing and implementing risk-based strategies to strengthen public health protections. In this effort, we are expanding our enforcement activities against illegal online sales; we are collaborating with other Federal law enforcement agencies, State Boards of Health and Boards of Pharmacy, and professional organizations to better coordinate enforcement efforts; and we have increased our public outreach efforts to warn consumers about dangerous practices involving Internet sites that sell drugs not approved by FDA, or sites that offer prescription drugs with little or no involvement or interaction with a health care professional.

Once products are approved for marketing, the management of risks and benefits to patients becomes the shared responsibility of many in the health care system. The agency values the contributions that the medical community can make to managing medical product risks. By working together in this area, perhaps we can reduce the risks of prescription products that could be harmful to patients and consumers.

I know that there are many challenges and opportunities that we will be faced with in the coming years-some we know about, others will emerge as we move ahead. In the words of John Dewey, "To the being fully alive, the future is not ominous but a promise; it surrounds the present like a halo." I look forward to the future of the Food and Drug Administration, and to working with organizations such as yours in that future. Thank you.